Identity
- Trade Name
- UltraMIST Generator FDA UDI
- Generic Name
- Wound therapy ultrasound system FDA UDI
- Device Name
- The UltraMIST Generator FDA UDI
- Model / Reference
- CP-80031 FDA UDI
- Description
- The UltraMIST Generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812265010317 FDA UDI
- 510(k) Number
- K140782 FDA UDI
- FDA Product Code
- NRB FDA UDI
- GMDN Term
- Wound therapy ultrasound system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wound therapy ultrasound system
UltraMIST Generator by SANUWAVE Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound therapy ultrasound system.
- UltraMIST Treatment Wand — SANUWAVE Health, Inc. · Class II
- UltraMIST Single Use Applicator (12 Pack) — SANUWAVE Health, Inc. · Class II
- UltraMIST Single Use Applicator — SANUWAVE Health, Inc. · Class II
Cleared under the same submission
K140782 also covers:
- UltraMIST Applicator — ALLIQUA BIOMEDICAL, INC.
- UltraMIST Generator — ALLIQUA BIOMEDICAL, INC.
- UltraMIST Treatment Wand — ALLIQUA BIOMEDICAL, INC.
- UltraMIST Single Use Applicator — SANUWAVE Health, Inc.
- UltraMIST Single Use Applicator (12 Pack) — SANUWAVE Health, Inc.
- UltraMIST Treatment Wand — SANUWAVE Health, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SANUWAVE Health, Inc.
Sources (1)
- FDA UDI c4954e14-35bf-482a-bac9-789cae03c679 36 fields · synced Jun 8, 2026